40 CFR §159.188

1. (a)Microorganisms that pose a risk to human health. Information must be submitted which concerns either incidents described in paragraph (a)(1) of this section or a study described in paragraph (a)(2) of this section:
   1. (1)Information which concerns an incident which meets all of the following conditions:
      1. (i)The registrant has been informed that a pesticide product may not have performed as claimed against target microorganisms.
      2. (ii)The possible failures of the pesticide to perform as claimed involved the use against microorganisms which may pose a risk to human health.
      3. (iii)The pesticide product's use site is other than residential.
      4. (iv)The registrant has or could obtain information concerning where the incident occurred, the pesticide or product involved, and the name of a person to contact regarding the incident.
   2. (2)A study which indicates that the pesticide may not perform in accordance with one or more claims made by the registrant regarding uses intended for control of microorganisms tha may pose a risk to human health, including any of the public health antimicrobials identified in part 161 of this chapter.
2. (b)Animals that pose a risk to human health. For the purposes of this section, any animal (including insects) poses a risk to human health if it may cause disease in humans, either directly or as a disease vector; produce toxins that are harmful to humans; or cause direct physical harm to humans. Information must be submitted which concerns either incidents described in paragraph (b)(1) of this section or a study described in paragraph (b)(2) of this section.
   1. (1)Information which concerns an incident which meets all of the following conditions:
      1. (i)The registrant has been informed by municipal, State, or Federal public health officials that a pesticide product may not have performed as claimed against target animals.
      2. (ii)The possible failures of the pesticide to perform as claimed involved the use against animals that pose a risk to human health.
      3. (iii)The registrant has or could obtain information concerning where the incident occurred, the pesticide or product involved, and the name of a person to contact regarding the incident.
   2. (2)A study which indicates that the pesticide may not perform in accordance with one or more claims by the registrant regarding uses intended for control of animals that pose a risk to human health, including any of the public health pesticides identified in part 158 of this chapter.
3. (c)Development of pesticide resistance. Information must be submitted concerning substantiation of any incident of a pest having developed resistance to any pesticide (both public health and non-public health) that occurred under conditions of use, application rates and methods specified on the label if either of the following conditions is met:
   1. (1)The survival of the suspected pesticide-resistant pest was significantly higher than that of a known susceptible pest when both the suspected resistant and susceptible pests were treated with the pesticide under controlled conditions.
   2. (2)Biochemical tests or DNA sequencing indicate that the pest is resistant to the pesticide.